Quality of Life Assessment in Daily Clinical Oncology Practice for Patients With Advanced Renal Cell Carcinoma (QUANARIE)
Renal Carcinoma Metastatic, Kidney Neoplasms, Renal Cancer
About this trial
This is an interventional other trial for Renal Carcinoma Metastatic focused on measuring Health Related Quality of Life, Routine clinical practice, Electronic Patient Reported Outcome, EORTC QLQ-C30, Pazopanib, Sunitinib, Tyrosine Kinase Inhibitor anti-VEGF, Patient Reported Outcome, Supportive Care, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Patient with renal clear cells carcinoma, histologically or cytologically confirmed, locally advanced nonresectable or metastatic who initiate an oral treatment by ITK anti-VEGF (Pazopanib or Sunitinib.)
- Estimated life expectancy over than 3 months.
- Male or female
- Aged 18 years or older
- Patient able to understand French and to complete study questionnaires (no major cognitive disorders)
- Signed informed consent
- Patient affiliated to or beneficiary of French social security regime
Exclusion Criteria:
- Prior systemic treatment for metastatic renal cancer other than immunotherapy. Pretreatment or concomitant treatment with Biphosphonate or Denosumab is allowed.
- Renal carcinoma without clear cell component.
- Psychiatric illness compromising understanding of the information or conducting the study.
- Any acute or chronic disease (eg severe COPD) may affect the patient's ability to receive treatment under study or may make it difficult the interpretation of toxicities or adverse events.
- HIV positive.
- History of active chronic hepatitis including subjects who are carriers of Hepatitis B virus or Hepatitis C virus
- Uncontrolled infection
- History of digestive pathology which could compromise the good absorption of an oral ITK.
- Pregnancy, breast-feeding or absence/refusal of adequate contraception for fertile patients during the period of treatment and for 4 months from the last treatment administration.
- Hypersensitivity or contraindication to any of the study drugs (active substance of ITK or any excipients.)
Sites / Locations
- CHU de Besançon
- Hôpital privé Sainte MarieRecruiting
- Centre de lutte contre le cancer Georges François LeclercRecruiting
- Hôpital Nord Franche-ComtéRecruiting
- Centre de lutte contre le cancer Jean GodinotRecruiting
- Groupe hospitaliser St-VincentRecruiting
- Hôpitaux Universitaires de StrasbourgRecruiting
- Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de LorraineRecruiting
Arms of the Study
Arm 1
Other
Electronic PRO
All patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation.